Point-of-care testing system

ABSTRACT

A point of care (POC) testing system and a method for configuration of a POC testing system are disclosed that provide a workflow solution for the configuration management of POC analyzers. In some embodiments, the system and method provide for convenient assisted workflows that enable efficient management of POC analyzer operator certifications.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to EP 15166152.7, filed May 2, 2015,which is hereby incorporated by reference.

BACKGROUND

The present disclosure generally relates to a point of care testingsystem and a method for configuration of a point of care testing system.

In vitro diagnostic testing has a major effect on clinical decisions,providing physicians with pivotal information. Particularly there isgreat emphasis on providing quick and accurate test results in criticalcare settings.

One field of diagnostic testing is conducted with large analyticalinstruments in laboratories. These instruments are operated by operatorsthat are educated to maintain and operate such instruments.

Another field of diagnostic testing is bedside testing, or point of caretesting (POCT). This type of diagnostic testing is performed mainly bynurses or medical staff primarily trained to operate the instrumentsavailable at the site of patient care, such as hospitals, emergencydepartments, intensive care units, primary care setting, medicalcenters, patient homes, a physician's office, a pharmacy or a site of anemergency.

Often, POCT needs to meet clinical and laboratory requirements for shortturnaround times in critical care. Rapid determination of time-criticalparameters (e.g. blood glucose, cardiac markers, blood gases, etc.) canaccelerate decision making in the emergency room, intensive care unitsor even in the primary care setting.

Major benefits are obtained when the output of a POCT device is madeavailable immediately. Results can be shared instantaneously with allmembers of the medical team enhancing communication by decreasingturnaround time (TAT).

POCT has become established worldwide and finds vital roles in publichealth. Potential operational benefits of POCT include: faster decisionmaking, reduced operating times, postoperative care time, reducedemergency room time, reduced number of outpatient clinic visits, reducednumber of hospital beds required, more optimal use of professional time.

While there are many benefits of using POCT devices in terms of theirconvenience, establishing POCT is challenging. Some of the biggestchallenges relate to engaging health care providers as testingpersonnel, all the while ensuring adherence to best laboratory practicesand regulatory agency standards. Thus POCT implementation requires asystematic approach that involves all stakeholders.

Therefore, there is a need for a POC system and method that provideconvenient, assisted workflow solutions for the configuration managementof POC analyzers to enable efficient replacement of POC analyzers and toenable traceable relocation of POC analyzers within, for example, ahospital.

SUMMARY

According to the present disclosure, a point of care (POC) testingsystem and method are presented. The POC system can comprise one or morePOC analyzer(s) for analyzing one or more patient sample(s). The one ormore POC analyzer(s) can each have an analyzer identifier foridentifying the one or more POC analyzer(s). The POC system can alsocomprise a portable computing device configured to identify the one ormore POC analyzer(s) based on the corresponding analyzer identifier. Theportable computing device can have a user interface configured toreceive a configuration command. The portable computing device cangenerate a configuration request according to the configuration command.The configuration request can comprise the analyzer identifier(s) of theidentified POC analyzer(s). The POC system can also comprise a serverfor storing system parameter(s) corresponding to the one or more POCanalyzer(s). The portable computing device can further be configured totransmit the configuration request to the server. The server can beconfigured to receive the configuration request, update at least onesystem parameter corresponding to at least one identified POCanalyzer(s), and transmit an analyzer update command comprising at leastone analyzer parameter update to at least one identified POCanalyzer(s). Finally, the POC system can also comprise a communicationnetwork configured to communicatively connect the one or more POCanalyzer(s) and the portable computing device with the server. The oneor more POC analyzer(s) can be configured to receive the analyzer updatecommand and to update at least one analyzer parameter according to thecorresponding analyzer parameter update

Accordingly, it is a feature of the embodiments of the presentdisclosure to provide convenient, assisted workflow solutions for theconfiguration management of POC analyzers to enable efficientreplacement of POC analyzers and to enable traceable relocation of POCanalyzers within, for example, a hospital. Other features of theembodiments of the present disclosure will be apparent in light of thedescription of the disclosure embodied herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following detailed description of specific embodiments of thepresent disclosure can be best understood when read in conjunction withthe following drawings, where like structure is indicated with likereference numerals and in which:

FIG. 1 illustrates a diagram of an embodiment of the point of care POCtesting system according to an embodiment of the present disclosure.

FIG. 2A illustrates an overview of the communication network accordingto an embodiment of the present disclosure.

FIG. 2B illustrates an overview of another communication networkaccording to an embodiment of the present disclosure.

FIG. 2C illustrates an overview of a yet another communication networkaccording to an embodiment of the present disclosure.

FIG. 2D illustrates an overview of a yet still another communicationnetwork according to an embodiment of the present disclosure.

FIG. 3 illustrates a use case diagram of the method for configuration ofa point of care POC testing system according to an embodiment of thepresent disclosure.

FIG. 4 illustrates a use case diagram of the method for configuration ofa point of care POC testing system, illustrating relocation of a POCanalyzer according to an embodiment of the present disclosure.

FIGS. 5A-B illustrate screenshots of a portable computing device;illustrating method steps of a relocation of a POC analyzer according toan embodiment of the present disclosure.

FIG. 6 illustrates a use case diagram of the method for configuration ofa point of care POC testing system, illustrating a replacement of afirst (defective) POC analyzer with a second (replacement) POC analyzeraccording to an embodiment of the present disclosure.

FIGS. 7A-D illustrate screenshots of a portable computing device;illustrating method steps of a replacement of a first (defective) POCanalyzer with a second (replacement) POC analyzer according to anembodiment of the present disclosure.

FIG. 8 illustrates a use case diagram of the method for configuration ofa point of care POC testing system, illustrating a certificationconfiguration corresponding to one or more operator(s) and one or morecertification(s) according to an embodiment of the present disclosure.

FIGS. 9A-D illustrate screenshots of a portable computing device,illustrating method steps of a certification configuration correspondingto one or more operator(s) and one or more certification(s) according toan embodiment of the present disclosure.

DETAILED DESCRIPTION

In the following detailed description of the embodiments, reference ismade to the accompanying drawings that form a part hereof, and in whichare shown by way of illustration, and not by way of limitation, specificembodiments in which the disclosure may be practiced. It is to beunderstood that other embodiments may be utilized and that logical,mechanical and electrical changes may be made without departing from thespirit and scope of the present disclosure.

Certain terms will be used in this patent application, the formulationof which should not be interpreted to be limited by the specific termchosen, but as to relate to the general concept behind the specificterm.

As used herein, the terms ‘comprises,’ ‘comprising,’ ‘includes,’‘including,’ ‘has,’ ‘having’ or any other variation thereof, areintended to cover a non-exclusive inclusion.

The terms ‘patient sample’ and ‘biological sample’ can refer tomaterial(s) that may potentially contain an analyte of interest. Thepatient sample can be derived from any biological source, such as aphysiological fluid, including blood, saliva, ocular lens fluid,cerebrospinal fluid, sweat, urine, stool, semen, milk, ascites fluid,mucous, synovial fluid, peritoneal fluid, amniotic fluid, tissue,cultured cells, or the like. The patient sample can be pretreated priorto use, such as preparing plasma from blood, diluting viscous fluids,lysis or the like. Methods of treatment can involve filtration,distillation, concentration, inactivation of interfering components, andthe addition of reagents. A patient sample may be used directly asobtained from the source or used following a pretreatment to modify thecharacter of the sample. In some embodiments, an initially solid orsemi-solid biological material can be rendered liquid by dissolving orsuspending it with a suitable liquid medium. In some embodiments, thesample is suspected to contain a certain antigen or nucleic acid.

The term ‘analyzer’ as used herein can encompass any apparatus forobtaining a measurement value from a patient sample. For example, theanalyzer can measure light absorption, fluorescence, electricalpotential or other physical or chemical characteristics of the reactionto provide the measurement data. Often such patient samples can betreated before analytical testing is done. Blood sampled from a patientcan be e.g. centrifuged to obtain serum or treated with anti-coagulantsto obtain plasma.

Analytical testing by an analyzer can have the goal to determine thepresence and/or concentration of an analyte in a patient sample. Theterm ‘analyte’ can be a general term for substances for whichinformation about presence and/or concentration is intended. Examples ofanalytes are e.g. glucose, coagulation parameters, endogenic proteins(e.g. proteins released from the heart muscle), metabolites, nucleicacids and so on. The term ‘patient health parameter’ as used herein canencompass any aspect of a patient's physiology that can be measurable orindicated by an analysis of a patient sample for one or more analyte.

The term ‘analytical data’ as used herein can encompass any data thatcan be descriptive of a result of a measurement of one or more patienthealth parameter(s) performed by a point-of-care (POC) analyzer of thebiological sample that has been analyzed. In case of a calibration, theanalytical data can comprise the calibration result, i.e. calibrationdata. In one embodiment, the analytical data can comprise an identifierof the patient sample for which the analysis has been performed and databeing descriptive of a result of the analysis, such as measurement data.

The term ‘workflow’ as used herein can encompass any task carried out bya human or a machine that can comprise one or more steps, such as formaintenance or operation of a system or one of its system components.

The term ‘step of a workflow’ as used herein can encompass any activitybelonging to a workflow.

The term ‘authentication data’ as used herein can encompass any kind ofdata suitable to identify an operator/user, such as a user name/user IDand/or password, a security token, a biometric identifier(s) or thelike.

The term ‘authentication and authorization unit’ as used herein canencompass any hardware-, firmware- and/or software-based module operableto execute program logic for receiving and processing authenticationdata. Furthermore the authentication and authorization unit can compriseany hardware-, firmware- and/or software-based module operable toexecute program logic for determining, if the authenticateduser/operator possesses the authorization to access a requestedfeature/data/resource/process/ or the like.

The term ‘point of care’ (POC) or ‘point of care environment’ as usedherein can be defined to mean a location on or near a site of patientcare where medical or medically related services such as medical testingand/or treatment can be provided, including but not limited tohospitals, emergency departments, intensive care units, primary caresetting, medical centers, patient homes, a physician's office, apharmacy or a site of an emergency.

The term ‘point of care testing’ (POCT) as used herein can encompassanalysis of one or more patient sample(s) in a point of careenvironment. POCT can often be accomplished through the use oftransportable, portable, and handheld instruments, but small benchanalyzers or fixed equipment can also be used when a handheld device isnot available—the goal being to collect the patient sample and obtainthe analytical data in a (relatively) short period of time at or(relatively) near the location of the patient.

The term ‘point of care analyzer’ as used herein can encompass anyanalyzer used in a point of care environment, such as (but not limitedto) blood glucose testing, coagulation testing, blood gas andelectrolytes analysis, urinalysis, cardiac markers analysis, hemoglobindiagnostics, infectious disease testing, cholesterol screening ornucleic acid testing NAT. Results may be viewed directly on the POCanalyzer(s) or may be sent to the POCT system and displayed in aLaboratory Information System (LIS) with central lab results, oralongside imaging results in a Hospital Information System (HIS).

The term ‘portable computing device’ as used herein can encompass anyelectronic appliance that can be moved from one location to anotherappliance without the need of using a tool or to sever a connection ofthe appliance with another, in particular any handheld battery poweredmobile appliance, including but not limited to a cellular telephone, asatellite telephone, a pager, a personal digital assistant (“PDA”), asmartphone, a navigation device, a smartbook or reader, a combination ofthe aforementioned devices, a tablet computer or a laptop computer.

The term ‘communication network’ as used herein can encompass any typeof wired or wireless network, including but not limited to a WIFI, GSM,UMTS or other wireless digital network or a wired network, such asEthernet or the like. For example, the communication network may includea combination of wired and wireless networks.

The term ‘server’ as used herein can encompass any physical machine orvirtual machine having a physical or virtual processor, capable ofaccepting requests from and giving responses accordingly. It can beclear to a person of ordinary skill in the art of computer programmingthat the term machine may refer to a physical hardware itself, or to avirtual machine such as a JAVA Virtual Machine (JVM), or even toseparate virtual machines running different Operating Systems on thesame physical machine and sharing that machine's computing resources.Servers can run on any computer including dedicated computers, whichindividually are also often referred to as ‘the server’ or sharedresources such as virtual servers. In many cases, a computer can provideseveral services and have several servers running. Therefore the termserver can encompass any computerized device that shares a resource toone or more client processes.

The term ‘server interface’ as used herein can encompass any hardware-,firmware- and/or software-based module operable to execute program logicto allow communication with an external entity (such as a server oranother interface).

The term ‘user interface’ as used herein can encompass any suitablepiece of software and/or hardware for interactions between an operatorand a machine, including but not limited to a graphical user interfacefor receiving as input a command from an operator and also to providefeedback and convey information thereto. Also, a system/device mayexpose several user interfaces to serve different kinds ofusers/operators.

In the field of bedside testing or point of care testing, the testingcan be done on patients typically by nurses, medical staff or doctorsbut also pharmacists who can be collectively called ‘operator(s)’herein. However, anyone who possesses the required certification may bean operator. A point of care coordinator (POCC) may be at the same timean operator of POC analyzer(s) and also an operator of POC analyzer(s)may be at the same time a point of care coordinator (POCC) and thus userof portable computing device(s).

The term ‘certification’ as used herein can encompass any form ofconfirmation of certain characteristics (such as training and/orexamination and/or educational background and/or accreditation) of anoperator. In particular a certification as disclosed herein may not berestricted to embodiments which are formally titled “certification” orphysical embodiments (such as a printed certification) having a relatedtitle. According to some embodiments, certification(s) can be providedby an entry of an operator on list(s) of certified operators allowed toperform a job/task/workflow or step of a workflow using one or more ofthe POC analyzers. The certification(s) according to some embodimentsmay be permanent and/or time-restricted certifications, meaning that thecertification corresponding to an operator can become invalid after acertain period of time. After a certification becomes invalid, therespective operator may need to become certified again (by taking atraining and/or passing a (re)examination), otherwise that operator mayno longer use the respective POC analyzer(s) or certainfeatures/functions thereof. The term ‘system certification’ as usedherein can encompass a certification stored on a server. According tosome embodiments, the system certification can relate to all POCanalyzers of the POC testing system. According to further embodiments,the system certification can relate to one or more POC analyzers of acertain type, class, namely POC analyzers having at least one commoncharacteristic. Examples of common characteristics of one or more POCanalyzers are: POC analyzers being capable of performing the same orsimilar analyses of patient sample(s); POC analyzers requiring the sameor similar operator training/examination/certification; POC analyzersfrom one manufacturer; POC analyzers at the same healthcare facility,etc. The term ‘analyzer certification’ as used herein can encompass anycertification stored on a POC analyzer. According to some embodiments,the analyzer certification can store any kind of representation of theoperators (such as a list of operator identifiers) authorized to performat least one job/task/workflow or step of a workflow using thatparticular POC analyzer, in particular operators authorized to analyzeone or more patient sample(s) using that particular POC analyzer.According to certain embodiments, each analyzer certification can bespecific to one particular POC analyzer. According to furtherembodiment(s), each analyzer certification can be specific to one ormore POC analyzers of a certain type, class. According to even furtherembodiment(s), the analyzer certification(s) may be identical to thesystem certification(s), but stored locally on the POC analyzer(s).

Since POCT performed near the patient can lead directly to diagnosticand therapeutic decisions, a POCT system can advantageously meetmultiple requirements (similar to requirements in laboratory testing,but often within shorter times). Examples of such requirements include:

-   -   Provide accurate and timely analyses and associate them with the        correct patient;    -   Ensure that operators are competent/certified for the use of the        POCT system;    -   Ensure proper operation, availability and configuration of the        analyzers;    -   Provide reports that are useful to the clinician treating the        patient; and    -   Document testing and Quality Control QC for audit purposes.

POCT can be performed using various POC analyzers such as (but notlimited to) analyzers for glucose, coagulation, blood gas, urinalysis,cardiac and molecular testing. Results may be viewed directly on the POCanalyzer(s) or may be sent to the POCT system and displayed in aLaboratory Information System (LIS) with central lab results, oralongside imaging results in a Hospital Information System (HIS).

POC analyzers can commonly be managed by a server, and in particular, ahardware management server, also called Point of Care Data ManagementSystem (POC-DMS). Such a server can provide connectivity for POCanalyzers and management of test results, operators, quality controls,and analyzers.

Management of POCT can be challenging—there can be dozens of sites,hundreds of POCT devices/kits, and thousands of operators to manage toassure quality of testing. One challenge in developing a strategy tomanage POCT usually can involve building a competent interdisciplinaryPOC management team including the laboratory, physicians, and nurses.The POC team can usually hold the responsibility for determining thetest menu, selecting technologies, establishing policies and procedures,ensuring training and regulatory compliance, and providing advisoryassistance to the end operators of POC technologies. After establishinga POC team, a management structure can often be built that isresponsible to implement new initiatives and to perform correctiveaction where necessary. The POC analyzers of a POCT system can generallybe managed by one or more Point of Care Coordinator(s) (POCC). The POCCcan be responsible for ensuring that all analyzers are up and running;that all operators are able to use the analyzer(s); know where theanalyzers and operators are; and make sure to be compliant to theregulatory expectations.

As illustrated on FIG. 1 for example, the point of care (POC) testingsystem 1 can comprises one or more POC analyzer(s) 10.1-10.n, a portablecomputing device 20 and a server 50 communicatively connected by acommunication network 70. In one embodiment, the communication network70 can be configured to communicatively connect the one or more POCanalyzer(s) 10.1-10.n and the portable computing device 20 with theserver 50.

The POC analyzer(s) 10.1-10.n can be provided and configured foranalyzing one or more patient sample(s) in order to measure one or morepatient health parameter(s). According to some embodiments, POCanalyzer(s) 10.1-10.n can include transportable, portable, and handheldinstruments and small bench analyzers or fixed equipment as well, suchas (but not limited to) blood glucose testing, coagulation testing,blood gas and electrolytes analysis, urinalysis, cardiac markersanalysis, hemoglobin diagnostics, infectious disease testing,cholesterol screening or nucleic acid testing (NAT). Several functionaland/or operational aspects of the POC analyzer(s) 10.1-10.n can beconfigurable/customizable using one or more analyzer parameter(s).

In order to identify a particular POC analyzer(s) 10.1-10.n, each can beprovided with an analyzer identifier such as, for example, an identifiertag, such as a barcode and/or an RFID tag but can be a serial number aswell.

The server 50 can be provided and configured for storing systemparameter(s) corresponding to the one or more POC analyzer(s) 10.1-10.n.Some of these system parameters are common for more than one POCanalyzers while some system parameters are specific to one singleindividual POC analyzer 10.1-10.n.

The at least one system parameter and/or analyzer parameter can include(but are not limited to) one or more of the following:

-   -   Analyzer specific parameters:    -   Formatting setting(s)    -   Language setting(s),    -   Date/Time format setting(s)    -   Shutdown/Sleep/Hibernate/Logout timeout    -   Connection configuration (e.g. wlan authentication data)    -   Analyzer Status: in use, backup, etc.    -   Security parameters    -   Authentication mechanism    -   Login mechanism (only user ID, user ID and Pwd or Barcode        scanning)    -   Patient identification/mapping parameters    -   Patient identification mechanism    -   Patient ID mapping    -   Measurement parameters    -   Default measurement unit(s)    -   Workflow definitions) (e.g. force having comments on results or        set them optional)    -   Ranges (such as reference ranges)    -   Quality Control (QC) parameters    -   QC Lockout    -   Lot verification    -   QC result display    -   Location specific parameters    -   Physical location: Healthcare Facility, Building, Floor, Unit,        Room    -   Logical location: Emergency room, intensive care units, primary        care setting, medical center, patient home, a physician's        office, a pharmacy or a site of an emergency    -   Location-specific authentication and authorization data.

In certain embodiments of the disclosed system/method, the server 50 canbe configured to:

-   -   retrieve analytical data from the one or more POC analyzer(s)        10.1-10.n such as data representing the measurement of patient        health parameter(s);    -   update program data of the one or more POC analyzer(s) 10.1-10.n        such as a software update.

The block arrows A and B of FIG. 1 illustrate an analyzer replacementrespectively an analyzer relocation workflow as described with referenceto the use case diagrams of FIGS. 4 and 6.

As shown on FIG. 1, the communication network 70 can be laidout/configured to communicatively connect the one or more POCanalyzer(s) 10.1-10.n and the portable computing device 20 with theserver 50, FIGS. 2A-D illustrate different embodiments thereof.

FIG. 2A shows a first embodiment of the communication network 70,wherein the portable computing device 20 can be communicativelyconnected with the server 50 by a remote configuration network area 72,while the one or more POC analyzer(s) 10.1-10.n can be communicativelyconnected with the server 50 using a point of care communication networkarea 71. According to some embodiments, the remote configuration networkarea 72 can be a mobile telecommunication network (such as a wirelessmobile Internet service, for example, a 3G, 4G or LTE standard) providedby a mobile data carrier service. On the other hand, the point of carecommunication network area 71 (of some embodiments of the communicationnetwork 70) can be a separate network, for example a combination ofwired and wireless networks, wherein the healthcare facilities (such asdifferent locations/buildings/floors) can be linked by a wiredcommunication network while the individual POC analyzer(s) 10.1-10.n canconnect via wireless access points in-between.

As shown on FIG. 2A, according to certain embodiments, there can be noneed for a communication between the portable computing device 20 andthe POC analyzer(s) 10.1-10.n as the (re)configuration thereof is alwayscarried out via the server 50.

Nevertheless, according to another embodiment of the communicationnetwork 70, as illustrated on FIG. 2B, the portable computing device 20and the POC analyzer(s) 10.1-10.n can be communicatively connected by aportable device to analyzer network area 73. In this case, the portablecomputing device 20 can act as a router/access point for the POCanalyzer(s) 10.1-10.n, “sharing” its network connection therewith. Thisembodiment can be advantageous in use scenarios when the POC analyzer(s)10.1-10.n do not have direct communication with the server 50. This canbe the case for example in remote areas where the POC analyzers10.1-10.n cannot be connected to a point of care communication networkarea 71 (or not all of them), but the portable computing device 20 doeshave a network connection via the remote configuration network area 72.In other cases, it might not be economic to provide each POC analyzerwith a network connection. In further embodiment, where the portablecomputing device 20 does have a network connection via the remoteconfiguration network area 72 but not each POC analyzer, can be anemergency response, in which case, the POC analyzers 10.1-10.n may needto be deployed “in the field” in a short period of time. The disclosedsystem/method can be advantageous in such scenarios as well, since evenwithout each POC analyzer 10.1-10.n having a network connection of theirown, they can all be configured easily and consequently from a portablecomputing device 20, only the portable computing device 20 may need anetwork connection.

FIG. 2C shows a further embodiment of the communication network 70;where a portable device to analyzer network area 73 can be provided tocommunicatively connect the portable computing device 20 with a POCanalyzer 10.1-10.n. In this embodiment, the portable computing device 20may not be directly connected with the server 50, but via the portabledevice to analyzer network area 73, the POC analyzer(s) 10.1-10.n actingas a router/access point for the portable computing device 20, “sharing”their network connection therewith. This embodiment can be advantageousin POC environments where the POC analyzers 10.1-10.n are alreadycommunicatively connected with the server 50 but there is no mobiletelecommunication network (no signal) for the portable computing device20 to connect to the server 50. For example, there can be POCenvironments where a mobile telecommunication network may not bedesired/permitted, the POC analyzer(s) 10.1-10.n being connected to theserver 50 with a wired point of care communication network area 71.Nevertheless, a direct communication between the portable computingdevice 20 and the POC analyzer(s) 10.1-10.n (for example via Bluetoothor IR) can still be possible/allowable.

FIG. 2D shows a further embodiment of the communication network 70,where, in addition, to a remote configuration network area 72 and apoint of care communication network area 71, a portable device toanalyzer network area 73 can also be provided. This embodiment canprovide both flexibility and redundancy for the communicative connectionof the one or more POC analyzer(s) 10.1-10.n and the portable computingdevice 20 with the server 50.

It may be pointed out however, that the particular implementation of thecommunication network 70 (as illustrated on FIGS. 2A-D) is to a certaindegree transparent to the POC testing system 1 and may not negativelyaffect the disclosed configuration method(s) as all embodiments of thecommunication network 70 disclosed herein can be configured tocommunicatively connect the one or more POC analyzer(s) 10.1-10.n andthe portable computing device 20 with the server 50, be it directly orvia different network area(s), such as the point of care communicationnetwork area 71 and/or the remote configuration network area 72 and/orthe portable device to analyzer network area 73.

FIG. 3 shows a use case diagram of an embodiment of the method forconfiguration of a POC testing system 1. The symbols on the top of thediagram illustrate the actors of the workflow—the POC analyzers10.1-10.n, the portable computing device 20 and the server 50, while thesteps of the workflow are shown below, illustrating the “involvement” ofthe actors in the respective workflow step(s). Workflow steps of someembodiment(s) only are illustrated with dotted lines.

In one step, the portable computing device 20 can identify the POCanalyzer(s) 10.1-10.n based on the respective analyzer identifier.Corresponding to the particular analyzer identifier, the portablecomputing device 20 can comprise an identifier reader such as a barcodereader and/or an RFID reader to read the identifier tag and/or a userinterface for inputting a serial number of the one or more POCanalyzer(s) 10.1-10.n. Alternatively an imaging device (such as acamera) of the portable computing device 20 can be configured toidentify the POC analyzer(s) 10.1-10.n. It can be noted that theportable computing device 20 can be configured such that it can identifymore than one POC analyzer(s) 10.1-10.n at the same time or successivelyand thus initiate a reconfiguration of more than one POC analyzers10.1-10.n at the same time. The more than one POC analyzers 10.1-10.nidentified can be referred to as the identified POC analyzer(s)10.1-10.n.

In order to initiate/start a configuration workflow (process), aconfiguration command can be given (by an operator). Therefore, theportable computing device 20 can be provided with a user interface 22configured to receive the configuration command. According to someembodiments of the user interface 22, the configuration command may be apush of a button (physical or screen button) a voice command, aselection in a menu, etc. The configuration command may be any form ofinput from an operator to initiate a configuration workflow (process).

Triggered by the configuration command, the portable computing device 20can generate a configuration request comprising the analyzer identifierof the identified POC analyzer(s) 10.1-10.n. After generating it(optionally after confirmation from the operator), the portablecomputing device 20 can transmit the configuration request to the server50. Therefore, the configuration request can be described as a sort oftranslation of the configuration command from the operator into arequest signal to the server 50.

The server 50 can be configured to receive the configuration request,the transmission thereof being performed using the communication network70. After receiving it, the server 50 can:

-   -   update at least one system parameter corresponding to the        identified POC analyzer(s) 10.1-10.n; and    -   transmit an analyzer update command comprising at least one        analyzer parameter update to the identified POC analyzer(s)        10.1-10.n.

The above steps by the server 50 will now be described in greaterdetail. On one hand, the server 50 can be configured to update at leastone system parameter corresponding to the identified POC analyzer(s)10.1-10.n. The server 50 can retrieve (can look up) the correspondingsystem parameter(s) as the configuration request generated by theportable computing device 20 can comprise the analyzer identifier(s).Depending on the configuration command/configuration request, the server50 can update the appropriate system parameter(s).

In order to ensure that the configuration command (as a completeworkflow) is implemented not only on the server 50 but across the POCtesting system 1, the server 50 can be configured to transmit ananalyzer update command(s) comprising at least one analyzer parameterupdate to the identified POC analyzer(s) 10.1-10.n which, in turn, canbe configured to receive the analyzer update command and to update atleast one analyzer parameter according to the corresponding analyzerparameter update. According to some embodiments and according to theparticular POC analyzer(s) 10.1-10.n, the updating of an analyzerparameter may become effective immediately, upon the nextstart-up/restart/docking etc. of the analyzer.

In other words, the configuration command given via the user interface22 of the portable computing device 20 can initiate a system-wideconfiguration workflow, wherein within the configuration workflow, theportable computing device 20, the server 50 and the POC analyzers10.1-10.n can collaborate (via the communication network) to ensure thatrequired parameters (system parameters and analyzer parameters alike)can be updated across the POC testing system 1. This approach can havethe advantage that a single configuration command can be given from aremote location (remote meaning a location different from the server) inorder to (re)configure the POC testing system 1—including any number ofPOC analyzers, the POC testing system 1 being configured such as toimplement the configuration command without the need for additionalactions/steps by the operator. Thus both operator effort and probabilityof operator error can be greatly reduced, as there is no need for theoperator to individually update system parameters on the server 50,identify the corresponding analyzer parameters and then update therespective POC analyzers 10.1-10.n. These steps can be taken over by thesystem/method. Therefore, some embodiments can be particularlyadvantageous over existing solutions, which commonly perform only theupdate of the system parameters on a server, wherein the operator isresponsible to perform the update of the analyzer parameters of therespective POC analyzer(s).

According to some embodiments, the steps of:

-   -   the server 50 transmitting an analyzer update command;    -   the POC analyzer(s) 10.1-10.n receiving the analyzer update        command; and    -   the POC analyzer(s) 10.1-10.n updating of at least one analyzer        parameter can be initiated by one or more POC analyzer(s)        10.1-10.n requesting an analyzer update. Correspondingly, the        one or more POC analyzer(s) 10.1-10.n can be configured to        request an analyzer update on occurrence(s) of certain event(s)        and/or at regular intervals. According to some embodiments, such        event(s) can comprise (but are not limited to) a login by an        operator; a startup/shutdown/docking/undocking (into a docking        station) of the POC analyzer 10.1-10.n. According to some        embodiments, the regular intervals (when the one or more POC        analyzer(s) 10.1-10.n are configured to request an analyzer        update) can be chosen to coincide with work shift changes of the        operators or with time intervals when—based on historical        data—the POC analyzers are least expected to be used. Thus the        regular intervals can be configured such as to minimize        unavailability (or predicted unavailability) of the POC        analyzer(s) 10.1-10.n.

To summarize the analyzer update(s)—according to some embodiments—theanalyzer update(s) may be implemented using “server push” technology(that is server initiated) and/or a “client pull” technology (client—inthis case POC analyzer initiated). The server push implementation of theanalyzer update can be advantageous for POC analyzers 10.1-10.n whichare continuously communicating with the server 50, while the client pullimplementation of the analyzer update can be advantageous for POCanalyzers 10.1-10.n which communicate with the server 50 only on anevent basis, such as periodically and/or upon a login by an operatorand/or upon startup and/or upon shutdown of the respective POC analyzer10.1-10.n.

Some embodiments can be particularly advantageous as they can allow adecentralized control of POC analyzers by a portable computing device.The disclosed solution can allow communication with hardware managementsoftware (such as the COBAS IT 1000 of Roche Diagnostics) through aportable computing device, making it possible to (re) configure POCanalyzer(s) and at the same time can also initiate the correspondingserver update(s). This combined update of both system parameter(s) andanalyzer parameter(s) can ensure consistent (re)configuration of the POCtesting system within a single workflow.

A common task of a POCC can be the relocation of a POC analyzer(s),necessary due to changed organizational structure or workloadfluctuations within the healthcare facilities. The physical relocationof a POC analyzer(s) usually can also trigger the need to updatecorresponding settings of the server (hardware management server) andalso reconfiguration of one or more parameters of the POC analyzer(s).For example, when a POC analyzer(s) is relocated from a children'shospital ward to an adult's ward, certain parameters of the POCanalyzer(s) may need to be updated accordingly to ensure the analyzerprovides accurate results. Furthermore, not only parameters of the POCanalyzer(s) but also settings of the server (hardware management server)may need to be updated to reflect the change in authorization of the useof the respective POC analyzer(s) by personnel in the adult's wardauthorized to perform diagnostic procedures on adult's samples.

Using known POC testing systems managed by known servers (hardwaremanagement server), the POCC may need to catalog all analyzer(s) to berelocated, change their corresponding settings in the server (hardwaremanagement server) at his workstation. Also, the POCC may need tophysically locate each POC analyzer(s), change their respective settingsto reflect the relocation. This process may be not only time-consumingbut also error prone. Therefore, the POCC has no convenient andefficient means to replace a non-functional POC analyzer(s) with abackup analyzer(s) using known point of care (POC) testing systems.While this process is feasible in a healthcare facility with a limitednumber of analyzers, it can be a real challenge when a POCC isresponsible for hundreds if not thousands of POC analyzers.

However, none of the known systems offer convenient workflow(s) to(re)configure POC analyzers remotely, (re) configuration workflow(s)such as relocation of one or more POC analyzer(s) or replacement ofnon-functional POC analyzer(s) with backup analyzer(s).

According to further embodiments, the configuration command can comprisea relocation command corresponding to a relocation of one or more POCanalyzer(s) 10.1-10.n, which can be transmitted to the server 50, whichcan update one or more system parameter(s) in accordance with therelocation of the identified POC analyzer(s) 10.n-10.n and can retrieveat least one analyzer parameter update in accordance with the relocationof the identified POC analyzer(s) 10.n-10.n to be transmitted within theanalyzer parameter update to the identified POC analyzer(s) 10.n-10.n.

FIG. 4 shows a use case diagram of an embodiment for configuration of aPOC testing system 1, illustrating a relocation workflow of a POCanalyzer 10.1-10.n. The relocation can comprise both a physical and/orlogical relocation of one or more POC analyzer(s) 10.1-10.n. Forexample, a physical relocation can refer to a change of physicallocation from one healthcare facility/building/building floor etc. toanother. On the other hand, the logical relocation can refer to a changein the reassignment of one or more POC analyzer(s) 10.1-10.n, forexample, between different hospital wards, emergency departments,intensive care units, primary care setting, medical centers, patienthomes, a physician's office, a pharmacy or a site of an emergency.

As shown on the use case diagram of FIG. 4 and the screenshots of FIGS.5A-B, the configuration command received by the portable computingdevice 20 can comprise a relocation command corresponding to arelocation of one or more POC analyzer(s) 10.1-10.n. This may be in theform of a selection of a physical and/or logical location from a list, amap or manual input of a location or a combination thereof.

As shown on FIG. 4, according to embodiments directed towards arelocation of POC analyzer(s) 10.1-10.n, the server 50 can be configuredto update one or more system parameter(s) in accordance with therelocation of the identified POC analyzer(s) 10.1-10.n and to retrieveat least one analyzer parameter in accordance with the relocation of theidentified POC analyzer(s) 10.1-10.n to be transmitted within theanalyzer parameter update to the identified POC analyzer(s) 10.1-10.n.For example, upon receiving a relocation command comprising as newlocation a children's hospital ward, the server 50 can retrieve allanalyzer parameters such as different reference values (as differentvalues apply when analyzing patient samples of children as compared toadults), new workflow definitions (as different locations may usedifferent workflows), new QC parameters, etc. The analyzer parametersretrieved in this step can be referred to as retrieved analyzerparameters.

As a following step, the server 50 can transmit the retrieved analyzerparameter(s) to the POC analyzer(s) 10.1-10.n to be relocated (that isthe identified POC analyzer(s) 10.1-10.n by the portable computingdevice 20).

One further aspect of the maintenance operations of a POCC can be toreplace a non-functional POC analyzer(s) with a backup analyzer(s)and/or to relocate a POC analyzer(s) as needed, these operationsincluding (re) configuration of the respective POC analyzer(s) and theserver (hardware management server) according to thereplacement/relocation of analyzer(s).

Using available POC testing system(s) managed by known hardwaremanagement servers, the POCC can fetch the non-functional POCanalyzer(s) and the backup analyzer(s) and change their allocation onthe server at his workstation, updating all the corresponding settingsso that the backup analyzer(s) take the place of the non-functional POCanalyzer(s). Thereafter, the POCC (or an assistant/nurse etc.) may needto take the (now replaced) POC analyzer(s) to the location where it isneeded. When a POCC is responsible for hundreds of analyzers possibly atdifferent locations, this can be a tedious and time-consuming task,which can be especially problematic in an environment where clinicaldecision making in the emergency department, intensive care units orprimary care setting is dependent on analysis to be performed by thereplacement analyzer.

Alternatively, the operator (an assistant/nurse) of the non-functionalPOC analyzer(s) can call (or email or notify by other suitable means)the POCC and provide him with the details of the non-functional POCanalyzer(s)—such as its identifier (e.g. barcode) so that the POCC canupdate all the corresponding settings so that the backup analyzer(s)take the place of the non-functional POC analyzer(s). However, thissolution can also be time-consuming and error-prone, especially as oftenit is only the POCC—who already travelled onsite—the one to determinethat the POC analyzer(s) is non-functional and needs to be replaced.

Therefore, the POCC can have no convenient and efficient means toreplace a non-functional POC analyzer(s) with a backup analyzer(s) usingknown systems.

According to further embodiments, the configuration command can comprisea replacement command corresponding to a replacement of a first POCanalyzer 10.1 (e.g. a broken analyzer) with a second POC analyzer 10.2(e.g. a replacement analyzer). The replacement command can betransmitted by the portable computing device 20 to the server 50, whichcan retrieve one or more system parameter(s) corresponding to the firstPOC analyzer 10.1, can update therewith respective system parameter(s)corresponding to the second POC analyzer 10.2, and can retrieve one ormore analyzer parameter(s) corresponding to the first POC analyzer 10.1to be transmitted within the analyzer parameter update to the second POCanalyzer 10.2.

FIG. 6 shows a use case diagram of an embodiment illustrating areplacement workflow of a first POC analyzer 10.1 with a second POCanalyzer 10.2. The replacement of the first POC analyzer 10.1 may berequired for several reasons, including (but not limited to) replacementof a non-functional (broken) or not-fully-functional (partially broken)analyzer with a backup analyzer with identical or at least similarcapability(s) of analyzing one or more patient sample(s). The term‘non-functional’ or ‘not-fully-functional’ with reference to a POCanalyzer can mean that the particular POC analyzer is at least at thatmoment not capable to perform or not capable to perform at a requiredquality/speed at least one of its functions, such as the analysis of apatient sample. Thus the term ‘non-functional’ or ‘not-fully-functional’do not necessarily mean that the POC analyzer is completelydefective/broken. Furthermore, the term ‘non-functional’ or‘not-fully-functional’ can comprise software- and/or hardware aspects ofnon-functionality.

Alternatively, an analyzer may be replaced with a different analyzerwhich is at the time not in use or when the priority of analyzing morepatient sample(s) so requires. In a different usage scenario, thereplacement workflow of a first POC analyzer 10.1 with a second POCanalyzer 10.2 can be performed within an update/exchange or maintenanceof the POC testing system 1.

As illustrated in FIG. 6, the portable computing device 20 can identifya first POC analyzer 10.1 which may need to be replaced and a second POCanalyzer 10.2 based on the corresponding analyzer identifier(s).Thereafter, the device replacement command can be received (as shown inFIG. 7B) corresponding to a replacement of the first POC analyzer 10.1with the second POC analyzer 10.2. According to some embodiments, thereplacement command can be comprised within the configuration command.Alternatively, a separate command may be given by the operator via theuser interface 22.

According to some embodiments, the replacement command can be receivedbefore the second POC analyzer 10.2 is identified.

After receiving the replacement command and identifying both the firstPOC analyzer 10.1 which needs to be replaced and the second POC analyzer10.2, the portable computing device 20 can generate the configurationrequest comprising the replacement command and the analyzer identifierscorresponding to the first POC analyzer 10.1 and to the second POCanalyzer 10.2.

As shown on FIG. 6, the server 50 can be configured to retrieve one ormore system parameter(s) corresponding to the first POC analyzer 10.1and update therewith respective system parameter(s) corresponding to thesecond POC analyzer 10.2. The system parameters retrieved in this stepcan be referred to as retrieved system parameters. In other words, thesystem parameters corresponding to the first POC analyzer 10.1 can becopied/moved to update the system parameter(s) for the second POCanalyzer 10.2. After updating the system parameters, the second POCanalyzer 10.2 can take the place of the first POC analyzer 10.1 in thePOC testing system 1. However, in order for the replacement to be fullycompleted and for the operator to perceive and be able to use the secondPOC analyzer 10.2 as it would be the first POC analyzer 10.1 (at leastfunctionally—in case the two analyzers are not identical in appearance),analyzer parameter(s) corresponding to the first POC analyzer 10.1 canbe retrieved by the server 50 and sent to the second POC analyzer 10.2as analyzer parameter update(s). The analyzer parameters retrieved inthis step can be referred to as retrieved analyzer parameters.

Since the second POC analyzer 10.2 can be configured to receive analyzerupdate command(s) and to update at least one analyzer parameteraccording to the corresponding analyzer parameter update, the analyzerparameters of the first POC analyzer 10.1 can be copied/moved to thesecond POC analyzer 10.2.

Therefore, some embodiments directed towards an analyzer replacement canbe particularly advantageous as they can provide a simple and efficientworkflow solution to replacing a POC analyzer by a single command givenon a portable computing device, wherein the system/method can take careof the necessary steps (on the server and the involved POC analyzers) sothat thereafter an operator can use the replacement POC analyzerproviding the same functionalities and/or same setup/configurationand/or user rights, etc. as the POC device which had to be replaced.This can ensure a very positive user experience as service/maintenanceand/or analyzer update activities can be made transparent to theoperator and downtime of a particular type of POC analyzer can beeliminated or at least minimized.

According to some embodiments, the server 50 can be configured to flagthe first POC analyzer 10.1 as inactive after updating the systemparameter(s) corresponding to the second POC analyzer 10.2. The POCC canthen inspect POC analyzers flagged or have them inspected by atechnician. After repair (hardware and/or software), the inactive flagof the respective POC analyzers can be removed and can become availablefor use again, be it immediately or as a backup analyzer for use asreplacement.

A further challenge in the management of POCT can be posed by theconfiguration management of operator training and of the correspondingtraining certification(s). Traditionally, the management of operatortraining/certification(s) implies that training/certification data hasto be entered centrally often even manually in a paper based approach.An obvious consequence of this type of training/certification managementis that the probability of an error or delays can be higher. Thissituation can have a high impact on efficiency and can even create someissues regarding the speed of patient care.

However, the certification management of prior art solutions isperformed centrally. This approach has several disadvantages, especiallyin dynamic point of care environments with a high number of operatorsrequiring training (in the thousands to tens of thousands acrossmultiple healthcare facilities), a high turnover rate of operators whomay be transferred between different departments and operators withdiverse educational backgrounds. Thus, in comparison with a more staticenvironment where trainings and examinations can be planned in advanceand corresponding certificates can be managed centrally, in a dynamicenvironment there can be a need to be able to perform the management ofoperator training/certification/status in an ad-hoc manner and if neededboth on-site—namely at or near the particular POC analyzer, the patientand/or the healthcare staff (the operator)—or off-site—which may benecessary in cases when it may not be feasible for the point of carecoordinator to relocate (for time/distance/resource constraints).

According to further embodiments, the configuration of the POC testingsystem 1, in order to manage operator certifications, can be performedas follows:

-   -   one or more system certification(s) 30.1-30.m, each        corresponding to one or more POC analyzer(s) 10.1-10.n can be        stored on the server 50;    -   operators of the POC testing system 1 can be provided with        corresponding operator identifier(s);    -   one or more certification(s) 30.1-30.m can be selected via the        user interface 22 of the portable computing device 20;    -   one or more operator(s) can be identified using the operator        identifier(s);    -   a certification configuration command can be given via the user        interface 22 of the portable computing device 20;    -   a certification configuration request can be generated by the        portable computing device 20, the certification configuration        request comprising:        -   the one or more operator identifier(s) corresponding to the            identified operator(s); and        -   data identifying the selected system certification(s)            30.1-30.m;    -   the server can receive the configuration request;    -   the server 50 can update the selected system certification(s)        30.1-30.m according to the certification configuration request;    -   the server 50 can transmit an analyzer certification update for        each of the selected system certification(s) 30.1-30.m to the        corresponding POC analyzer(s) 10.1-10.n;    -   the one or more POC analyzer(s) 10.1-10.n can receive the        analyzer certification update;    -   the one or more POC analyzer(s) 10.1-10.n can update their        respective analyzer certification according to the analyzer        certification update.

Such embodiments can be particularly advantageous for allowing adecentralized control of analyzer certifications and permitting a pointof care coordinator to easily add/delete/update operators (their status)to the system. Status update(s) can be related to the completion oftraining/successful examination or an operator access update. This waysuch management steps can be done immediately via a portable computingdevice in an efficient and secure manner.

FIG. 8 shows a use case diagram of further embodiments of a POC testingsystem illustrating a certification configuration corresponding to oneor more operator(s) and one or more certification(s).

According to some embodiments, the server 50 can further be configuredfor storing one or more system certification(s) 30.1-30.m, eachcorresponding to one or more POC analyzer(s) 10.1-10.n. As shown on FIG.9A, according to some embodiments, the server 50 can be configured tostore a system certification 30.1-30.m for each type/class of POCanalyzers. For this, analyzers of the same type/class (with similarfunctionality of analyzing patient sample(s)) can be grouped and asystem certification 30.1-30.m can be stored for each type/class, eachsystem certification 30.1-30.m storing the operator identifier(s) ofeach operator certified to operate one or more POC analyzer(s) 10.1-10.nof the type/class. Alternatively, the server 50 can be configured tostore a system certification 30.1-30.m for each of the one or more POCanalyzer(s) 10.1-10.n.

In one step (in certain embodiments, the step being shown with dottedlines), the portable computing device 20 can be configured to requestthe one or more system certifications 30.1-30.m and/or a list of the oneor more system certifications 30.1-30.m from the server 50, while theserver 50 can be configured to transmit the one or more systemcertifications 30.1-30.m and/or a list of the one or more systemcertifications 30.1-30.m to the portable computing device 20.

Thereafter, one or more of the system certifications 30.1-30.m can beselected via the user interface 22 of the portable computing device 20as shown in FIG. 9A, these can be referred to as the selected systemcertifications 30.1-30.m.

For identifying operator(s) of the one or more POC analyzer(s) 10.1-10.nof the POC testing system 1, operator(s) can be provided with operatoridentifier(s), each operator identifier uniquely identifying therespective operators. Correspondingly, the portable computing device 20can be configured to identify one or more operator(s) of the POC testingsystem 1 using one or more operator identifier(s). The one or moreoperator(s) identified by the portable computing device 20 can bereferred to as the identified operator(s).

According to some embodiments, the one or more operator identifier(s)can be identifier tags, such as a barcode and/or an RFID tag and/or analphanumeric identifier. Correspondingly, the portable computing device20 can comprise an identifier reader such as a barcode reader and/or anRFID reader to read the identifier tag and/or input method (such as akeyboard or input field on a screen) for inputting an alphanumericidentifier of the one or more operator identifier(s). In addition oralternatively, a camera device may be provided to identify the operatorsbased on the operator identifier(s). In addition or alternatively,biometric identification of the operator(s) may be used.

After one or more operator(s) have been identified and one or morecertifications 30.1-30.m have been selected, a certificationconfiguration command can be received via the user interface 22 of theportable computing device 20. According to embodiments of the userinterface 22, the certification configuration command may be a push of abutton (physical or screen button) a voice command, a selection in amenu, etc. The certification configuration command may be any form ofinput from an operator to initiate a configuration workflow (process).

Initiated by the certification configuration command, the portablecomputing device 20 can generate a certification configuration requestcomprising:

-   -   the one or more operator identifier(s) corresponding to the        identified operator(s); and    -   data identifying the selected system certification(s) 30.1-30.m.

According to some embodiments, the certification configuration requesttransmitted by the portable computing device 20 to the server 50 cancomprise one or more of the following:

-   -   addition of an operator status corresponding to the identified        operator(s); and/or    -   removal of an operator status corresponding to the identified        operator(s); and/or    -   update of an operator status corresponding to the identified        operator(s).

After generating it (optionally after confirmation from the operator),the portable computing device 20 can transmit the certificationconfiguration request to the server 50. Therefore, the certificationconfiguration request can be described as a translation of thecertification configuration command from the operator into a requestsignal to the server 50.

After receiving the certification configuration request—via thecommunication network 70—the server 50 can:

-   -   update the selected system certification(s) 30.1-30.m according        to the certification configuration request; and    -   transmit an analyzer certification update for each of the        selected system certification(s) 30.1-30.m to the corresponding        POC analyzer(s) 10.1-10.n.

The above steps by the server 50 can now be described in greater detail.On one hand, the server 50 can be configured to update the selectedsystem certification(s) 30.1-30.m within the server 50 according to thecertification configuration request. On the other hand, in order toensure that the certification configuration command (as a completeworkflow) can be implemented not only on the server 50 but across thePOC testing system 1, the server 50 can be configured to transmit ananalyzer update for each of the selected system certification(s)30.1-30.m to the corresponding POC analyzer(s) 10.1-10.n.

According to some embodiments, the analyzer certification updatetransmitted by the server 50 to the corresponding POC analyzer(s)10.1-10.n can comprise one or more of the following:

-   -   one or more operator identifier(s) corresponding to the        identified operator(s) to be granted access the respective POC        analyzer 10.1-10.n; and/or    -   one or more operator identifier(s) corresponding to the        identified operator(s) to be denied access to the respective POC        analyzer 10.1-10.n; and/or    -   one or more operator identifier(s) corresponding to the        identified operator(s) to be granted limited access to the        respective POC analyzer 10.1-10.n.

According to some embodiments, the steps of:

-   -   the server 50 transmitting an analyzer certification update for        each of the selected system certification(s) 30.1-30.m to the        corresponding POC analyzer(s) 10.1-10.n;    -   the one or more POC analyzer(s) 10.1-10.n receiving the analyzer        certification update; and    -   the one or more POC analyzer(s) 10.1-10.n updating their        respective analyzer certification according to the analyzer        certification update        can be initiated by one or more POC analyzer(s) 10.1-10.n        requesting an update of the corresponding system        certification(s) 30.1-30.m. Correspondingly, the one or more POC        analyzer(s) 10.1-10.n can be configured to request analyzer        certification update(s) on occurrence(s) of certain event(s)        and/or at regular intervals. According to some embodiments, the        one or more POC analyzer(s) 10.1-10.n can be configured to        request an analyzer certification update upon a login by an        operator and/or upon startup and/or upon shutdown and/or upon        docking (into a docking station) of the respective POC analyzer        10.1-10.n. This is shown on the use case diagrams with dotted        lines.

To summarize the analyzer certification update(s), according to someembodiments, the analyzer certification update(s) may be implementedusing “server push” technology (that is server initiated) and/or a“client pull” technology (client—in this case POC analyzer initiated).The server push implementation of analyzer certification update(s) canbe advantageous for POC analyzers 10.1-10.n which are continuouslycommunicating with the server, while the client pull implementation ofanalyzer certification update(s) can be advantageous for POC analyzers10.1-10.n which communicate with the server only on an event basis, suchas periodically and/or upon a login by an operator and/or upon startupand/or upon shutdown of the respective POC analyzer 10.1-10.n. Also,according to some embodiments, the POC analyzers 10.1-10.n can requestan analyzer certification update from the server 50 upon expiry of avalidity of the respective system certification(s) 30.1-30.m.

According to some embodiments, as shown in FIG. 9B, receiving thecertification configuration command via the user interface 22 of theportable computing device 20 can comprise a selection of one or morecertification criteria via the user interface 22. Certification criteriacan comprise (but is not limited to) one or more of the following:

-   -   Classroom training;    -   Hands-on training;    -   Training on patient sample analysis;    -   Training on calibration and/or quality control.

In some embodiments according to which one or more certificationcriteria corresponding to one or more system certification(s) 30.1-30.mare defined, the one or more POC analyzer(s) 10.1-10.n can be configuredto control access of the identified operator(s) to the respective POCanalyzer 10.1-10.n according to the one or more certification criteriaof the selected system certification(s) 30.1-30.m. Such control ofaccess can comprise allowing an operator to use only certain functionsof the POC analyzer 10.1-10.n. For example, an operator who has thecertification criterion “Training on patient sample measurement” but notthe certification criterion “Training on calibration and/or qualitycontrol” may only perform patient sample analysis with the respectivePOC analyzer(s) 10.1-10.n but not calibration and quality control.

According to some embodiments, the server 50 can be further configuredto:

-   -   mark a list of authorized operators for each of the POC        analyzer(s) 10.1-10.n corresponding to the selected system        certification(s) 30.1-30.m as invalid; and/or    -   update a list of authorized operators for each of the POC        analyzer(s) 10.1-10.n corresponding to the selected system        certification(s) 30.1-30.m according to the analyzer        certification update.

In such embodiment(s) the analyzer certification update can comprise alist of authorized operators for the respective POC analyzer(s)10.1-10.n.

According to embodiments of the disclosed system/method, the POCanalyzer(s) 10.1-10.n can be configured to perform one or more of thefollowing:

-   -   blood glucose testing;    -   coagulation testing;    -   blood gas or electrolytes analysis;    -   urinalysis;    -   cardiac markers analysis;    -   hemoglobin diagnostics;    -   infectious disease testing    -   cholesterol screening;    -   nucleic acid testing (NAT).

According to some embodiments, the portable computing device 20 can beone of the following:

-   -   a mobile phone, in particular a smartphone;    -   a tablet computer;    -   a laptop computer;    -   a dedicated PDA device.

According to some embodiments, the server 50 can be configured to:

-   -   retrieve analytical data from the one or more POC analyzer(s)        10.1-10.n such as data representing the measurement of patient        health parameter(s);    -   update program data of the one or more POC analyzer(s) 10.1-10.n        such as a software update.

It will be understood that not all steps of the methods herein disclosedare necessarily carried out in the listed/described order. Inparticular, a configuration command may be received by the portablecomputing device before identifying POC analyzer(s); operators may beidentified before selecting a certification; analyzer update command(s)may be transmitted by the server to the POC analyzer(s) before updatingsystem parameter(s) or a first POC analyzer may be flagged as inactivebefore the second (replacement) POC analyzer is updated with theanalyzer parameters of the first POC analyzer.

It is noted that terms like “preferably,” “commonly,” and “typically”are not utilized herein to limit the scope of the claimed embodiments orto imply that certain features are critical, essential, or evenimportant to the structure or function of the claimed embodiments.Rather, these terms are merely intended to highlight alternative oradditional features that may or may not be utilized in a particularembodiment of the present disclosure.

Having described the present disclosure in detail and by reference tospecific embodiments thereof, it will be apparent that modifications andvariations are possible without departing from the scope of thedisclosure defined in the appended claims. More specifically, althoughsome aspects of the present disclosure are identified herein aspreferred or particularly advantageous, it is contemplated that thepresent disclosure is not necessarily limited to these preferred aspectsof the disclosure.

We claim:
 1. A method for configuration of a point of care (POC) testing system, the method comprising: providing one or more POC analyzer(s) for analyzing one or more patient sample(s); providing one or more operator identifier(s) corresponding to one or more operators of the POC testing system, each operator identifier uniquely identifying the respective operator; providing a portable computing device to a POC coordinator responsible for maintenance of the one or more POC analyzer(s), wherein the portable computing device is not a POC analyzer; providing a server for storing one or more system certification(s), each corresponding to one or more POC analyzer(s), wherein the one or more system certification(s) are certifications stored on the server and wherein a certification is indicative of user(s) being authorized to use one or more of the one or more POC analyzer(s) with respect to one or more functions of the one or more of the one or more POC analyzer(s); communicatively connecting the one or more POC analyzer(s) and the portable computing device with the server via a communication network; selecting by the POC coordinator one or more system certification(s) via a user interface of the portable computing device; identifying by the portable computing device one or more operator(s) using one or more operator identifier(s); receiving by the portable computing device a certification configuration command to update the server and the one or more POC analyzer(s) via the user interface of the portable computing device; in response to receiving the certification configuration command, generating by the portable computing device a certification configuration request indicative of the certification configuration command, the certification configuration request comprising, the one or more operator identifier(s) corresponding to the identified operator(s), and data identifying the selected system certification(s), wherein the certification configuration request further comprises one or more of the following: addition of an operator status corresponding to the identified operator (s) and/or removal of an operator status corresponding to the identified operator(s) and/or update of an operator status corresponding to the identified operator(s); transmitting by the portable computing device the certification configuration request to the server; receiving by the server the certification configuration request; updating by the server the selected system certification(s) according to the certification configuration request; transmitting by the server an analyzer certification update for each of the selected system certification(s) to the corresponding POC analyzer(s), wherein the analyzer certification update comprises one or more of the following: one or more operator identifier(s) corresponding to the identified operator(s) to be granted access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be denied access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be granted limited access to the respective POC analyzer; receiving by the one or more POC analyzer(s) the analyzer certification update; and updating by the one or more POC analyzer(s) their respective analyzer certification according to the analyzer certification update, wherein an analyzer certification is a certification stored on a POC analyzer.
 2. The method for configuration of a POC testing system according to claim 1, wherein the server transmitting an analyzer certification update for each of the selected system certification(s) to the corresponding POC analyzer(s), the one or more POC analyzer(s) receiving the analyzer certification update, and the one or more POC analyzer(s) updating their respective analyzer certification according to the analyzer certification update are initiated by one or more POC analyzer(s) requesting an analyzer certification update.
 3. The method for configuration of a POC testing system according to claim 2, wherein one or more POC analyzer(s) requests an analyzer certification update on occurrence(s) of certain event(s) and/or at regular intervals.
 4. The method for configuration of a POC testing system according claim 1, further comprising, storing one or more certification criteria corresponding to selected system certification(s) on the server; selecting one or more certification criteria via the user interface within the step of receiving the certification configuration command; including by the portable computing device the one or more certification criteria in the certification configuration request; controlling access of the identified operator(s) to the respective POC analyzer by the one or more POC analyzer(s) according to the one or more certification criteria of the selected system certification(s).
 5. The method for configuration of a POC testing system according to claim 1, wherein the one or more operator identifier(s) are identifier tags.
 6. The method for configuration of a POC testing system according to claim 1, wherein the portable computing device comprises an identifier reader.
 7. The method for configuration of a POC testing system according to claim 1, further comprising, retrieving by the portable computing device of one or more system certification(s) from the server.
 8. The method for configuration of a POC testing system according to claim 1, wherein the one or more system certification(s) comprises a list of authorized operators for a group of one or more POC analyzer(s).
 9. The method for configuration of a POC testing system according to claim 1, wherein the analyzer certification update comprises a list of authorized operators specific for the respective POC analyzer(s).
 10. A point of care (POC) testing system, the POC testing system comprising: one or more POC analyzer(s) for analyzing one or more patient sample(s), the POC analyzer(s) each having an analyzer identifier for identifying the POC analyzer(s); a server for storing one or more system certification(s), each corresponding to one or more POC analyzer(s), wherein the one or more system certification(s) are certifications stored on the server and wherein a certification is indicative of user(s) being authorized to use one or more of the one or more POC analyzer(s) with respect to one or more functions of the one or more of the one or more POC analyzer(s); a portable computing device of a POC coordinator responsible for maintenance of the one or more POC analyzer(s), the portable computing device is configured to identify one or more operator(s) of the POC testing system using one or more operator identifier(s), each operator identifier uniquely identifying the respective operator, wherein the portable computing device comprises a user interface configured to enable selection of one or more system certification(s) by the POC coordinator, wherein the portable computing device is not a POC analyzer, wherein the portable computing device is configured to receive a certification configuration command to update the server and the one or more POC analyzer(s) via the user interface, and wherein the portable computing device is configured to generate and transmit to the server, in response to receiving the certification configuration command, a certification configuration request indicative of the certification configuration command, the certification configuration request comprising one or more operator identifier(s) corresponding to the identified operator(s) and data identifying the selected system certification(s), wherein the certification configuration request further comprises one or more of: addition of an operator status corresponding to the identified operator (s) and/or removal of an operator status corresponding to the identified operator(s) and/or update of an operator status corresponding to the identified operator(s); and a communication network configured to communicatively connect the one or more POC analyzer(s) and the portable computing device with the server, wherein the server is configured to receive the certification configuration request, wherein the server is configured to update the selected system certification(s) within the server according to the certification configuration request, wherein the server is configured to transmit an analyzer certification update for each of the selected system certification(s) to the corresponding POC analyzer(s), the analyzer certification update comprising one or more of the following: one or more operator identifier(s) corresponding to the identified operator(s) to be granted access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be denied access to the respective POC analyzer and/or one or more operator identifier(s) corresponding to the identified operator(s) to be granted limited access to the respective POC analyzer, and wherein the one or more POC analyzer(s) are configured to receive the analyzer certification update and to update their respective analyzer certification according to the analyzer certification update, wherein an analyzer certification is a certification stored on a POC analyzer.
 11. The POC testing system according to claim 10, wherein the one or more POC analyzer(s) are configured to request an analyzer certification update on occurrence(s) of certain event(s) and/or at regular intervals.
 12. The POC testing system according to claim 10, wherein the portable computing device is configured to request the one or more system certifications and/or a list of the one or more system certifications from the server.
 13. The POC testing system according to claim 10, wherein the server is configured to transmit the one or more system certifications and/or a list of the one or more system certifications to the portable computing device. 